NCT05090904

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

A Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to placebo in participants with cystic fibrosis (CF) over the 4-week treatment period.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Brensocatib	Oral tablet
DRUG	Placebo	Oral tablet

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2021-10-25
• Last updated: 2026-03-12
• Results posted: 2026-03-12

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study